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Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tore Prestegaard, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier:
NCT00840229
First received: February 8, 2009
Last updated: November 24, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to compare ultrasound guided capsular corticosteroid injection into the rotator interval/anterior capsule and the GH joint with ultrasound guided corticosteroid injection into the GH joint only. Both methods will be compared with placebo injections.

Primary outcome measure: pain reduction at week 6 Secondary outcome measures: improvement of function (SPADI, Life quality, ROM).

0-hypothesis: no difference between the methods.

The investigators want to find out if the clinical effect of the combined capsular and intra-articular injections are better than placebo and better that intra-articular injections


Condition Intervention
Adhesive Capsulitis
Drug: Triamcinolone hexacetonide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rotator Interval and Intra-articular Corticosteroid Injection for Adhesive Capsulitis (Frozen Shoulder): a Randomised, Double Blind, Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Pain reduction [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Function (ROM, SPADI), Life quality [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: February 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 capsular & intra-articular
corticosteroid injection (Triamcinolone) in capsule/rotator interval and intra-articular
Drug: Triamcinolone hexacetonide
1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml
Active Comparator: 2 intra-articular
corticosteroid injection (Triamcinolone) intra-articular placebo injection (Lidocaine) in capsule
Drug: Triamcinolone hexacetonide
1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml
Placebo Comparator: 3 placebo
placebo injections (Lidocaine) in capsule and intra-articular
Drug: Triamcinolone hexacetonide
20 mg

Detailed Description:

3 groups, 50 patients in each, follow-up visits after 3, 6, 12 and 26 weeks.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pain and stiffness in one shoulder 1 - 6 months
  • Restriction of passive ROM; >= 30 degrees in two or more planes compared to other shoulder

Exclusion Criteria:

  • Systemic inflammatory disease
  • Corticosteroid treatment last 3 months
  • Poorly controlled Diabetes mellitus
  • Pregnancy
  • Contraindications/allergy to corticosteroids and/or Lidocaine
  • Severe infections
  • Osteoarthritis of the shoulder
  • Fractures of the shoulder
  • Rotator cuff pathology causing pain or disability
  • Fibromyalgia
  • Not able to understand Norwegian
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840229

Locations
Norway
Vestfold Hospitalt Trust, Clinic Physical Medicine and Rehabilitation
Stavern, Norway, 3294
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Tore A Prestgaard, MD Vestfold Hospital Trust
  More Information

No publications provided

Responsible Party: Tore Prestegaard, MD, consultant physician, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT00840229     History of Changes
Other Study ID Numbers: S-08546, REK, Interne tjenester, IT-avdelingen, Rikshospitalet HF
Study First Received: February 8, 2009
Last Updated: November 24, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
adhesive capsulitis
corticosteroids
injection
pain

Additional relevant MeSH terms:
Bursitis
Joint Diseases
Musculoskeletal Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014